Malaria, FalciparumPhase 3NCT00142246
Study of the Impact of Intermittent Preventive Treatment in Schools on Malaria, Anaemia and Education.
A Phase 3 study testing Intermittent preventive treatment (SP and amodiaquine) in people with Malaria, Falciparum, run by London School of Hygiene and Tropical Medicine at 1 site in Kenya.
Trial summary
This study seeks to establish whether intermittent preventive treatment (IPT) can reduce malaria among school-going children and its consequent impact on school performance. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malaria, Falciparum
- What is being tested?
- Intermittent preventive treatment (SP and amodiaquine)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6,758 participants
- Where
- 1 siteKenya
- Study dates
- Jan 2005to Apr 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Enrolled in primary school, and attending regularly
- Enrolled in nursery or classes 1-7
- Informed consent from parent or guardian
Who cannot join
- Enrolled in primary class 8
- Haemoglobin level below 70g/L at baseline
- History of reaction to sulfa drugs (e.g. fansidar, septrin)
- History of severe skin reaction to any drug
- Withdrawal criteria:
- Withdrawal of parental consent
- Haemoglobin level falling below 70g/L
- Severe adverse reaction to treatment
Trial locations and contacts
1 site in 1 country.
Kenya1 site
Primary schools within Bondo district / Bondo District Hospital
Bondo, Bondo District
About this study
Official title: Intermittent Preventive Treatment in Schools: a Randomised Controlled Trial of the Impact of IPT on Malaria, Anaemia and Education Amongst Schoolchildren in Western Kenya
This study seeks to establish whether intermittent preventive treatment (IPT) can reduce malaria among school-going children and its consequent impact on school performance.
Read the detailed description
Although the risk of malaria is greatest in early childhood, significant numbers of schoolchildren remain at risk from malaria-specific morbidity and mortality. Each year between 20-50% of schoolchildren, aged 10-14 years, living in malaria-endemic areas will experience a clinical attack of malaria (Clarke et al., 2004). Malaria accounts for 3-8% of all-cause absenteeism from school, and up to 50% of preventable absenteeism (Brooker et al., 2000). In addition, asymptomatic parasitaemia contributes to anaemia, reducing concentration and learning in the classroom (Holding \& Snow, 2001). Intermittent preventive treatment (IPT) delivered through schools is a simple intervention, which can be readily integrated into broader school health programmes. This study seeks to examine whether IPT can reduce malaria and anaemia amongst school-going children, and its consequent impact on school performance, in order to assess its suitability for inclusion as a standard intervention in school health programmes.
The efficacy of IPT is being evaluated in schoolchildren with a high-level of acquired immunity and ability to limit parasite growth, in whom most infections are asymptomatic and may go untreated.
The intervention: Intermittent preventive treatment of malaria administered each school term with the purpose to reduce asymptomatic parasitaemia and prevent clinical attacks, thereby reducing anaemia and school absenteeism, with consequences for improved attendance and concentration in class.
Schools are randomly allocated to one of two arms:
- Intervention schools: IPT given three times a year (once per term) + mass treatment with anthelminthics
- Control schools: mass treatment with anthelminthics only
Mass treatment with anthelminthics is carried out in all study schools twice annually in accordance with national policy.
- Conditions
- Malaria, Falciparum
- Being tested
- Intermittent preventive treatment (SP and amodiaquine), Placebo
- Keywords
- malaria, anaemia, school performance, education, intermittent preventive treatment, schools
- Medical subject headings
- Malaria, Falciparum, Malaria, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent preventive treatment (SP and amodiaquine)Drug
Oral medication. SP: single dose given over one day; amodiaquine: 3 daily doses over 3 days. Dosage has given according to age.
PlaceboOther
Three doses given over three days (Day 1: placebo SP + placebo AQ; Days 2 and 3: placebo AQ). Dosage given according to age
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intermittent preventive treatment with antimalarial drug combination(SP and amodiaquine) Receives: Drug: Intermittent preventive treatment (SP and amodiaquine) |
| 2 | Placebo comparator | Dual placebo comparator Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of anaemia (Hb <112g/L)
Measured: March 2006
Secondary outcomes (3)
Prevalence of Plasmodium falciparum parasitaemia
Measured: March 2006
Sustained attention
Measured: March 2006
Mean haemoglobin
Measured: March 2006
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Malaria, FalciparumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6,758 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nairobi
- Responsible party
- Principal investigator, Brian Greenwood, London School of Hygiene and Tropical Medicine
- Investigators
- Sian E Clarke, PhD, Principal investigator, London School of Hygiene and Tropical Medicine, University of London, UKSimon J Brooker, PhD, Principal investigator, London School of Hygiene and Tropical Medicine, University of London, UKBenson BA Estambale, MBChB, PhD, Principal investigator, University of NairobiMatthew CH Jukes, PhD, Principal investigator, Partnership for Child Development, Imperial College, University of London, UKPascal Magnussen, MD, Principal investigator, DBL - Institute for Health Research and Development, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00142246
- Sponsor's protocol ID
- ITDCVG41
- Status last verified
- Jan 2017
- First submitted
- 31 Aug 2005
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Clarke SE, Brooker S, Jukes MCH, Njagi JK, Khasakhala L, Otido J, Crudder C, McGlone B, Magnussen P & Estambale BBA. (2006). Randomised controlled trial of intermittent preventive treatment in schoolchildren: Impact on malaria, anaemia & school performance [abstract]. American Journal of Tropical Medicine & Hygiene Suppl 75 (5): 123.
Clarke S, Njagi J, Jukes M, Estambale B, Khasakhala L, Ajanga A, Luoba A, Otido J, Ochola S & Magnussen P. (2005). Intermittent preventive treatment in schools: Malaria parasitaemia, anaemia and school performance [abstract]. Acta Tropica, Suppl 95: S133.
Clarke SE, Jukes MC, Njagi JK, Khasakhala L, Cundill B, Otido J, Crudder C, Estambale BB, Brooker S. Effect of intermittent preventive treatment of malaria on health and education in schoolchildren: a cluster-randomised, double-blind, placebo-controlled trial. Lancet. 2008 Jul 12;372(9633):127-138. doi: 10.1016/S0140-6736(08)61034-X.
PubMed 18620950
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Preventive Treatment in Schools: a Randomised Controlled Trial of the Impact of IPT on Malaria, Anaemia and Education Amongst Schoolchildren in Western Kenya
- ClinicalTrials.gov ID
- NCT00142246
- Acronym / sponsor ID
- ITDCVG41
- Conditions
- Malaria, Falciparum
- Keywords
- malaria, anaemia, school performance, education, intermittent preventive treatment, schools
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,758 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- University of Nairobi
- Study start
- Jan 2005
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 2 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to establish whether intermittent preventive treatment (IPT) can reduce malaria among school-going children and its consequent impact on school performance.
Detailed description
Although the risk of malaria is greatest in early childhood, significant numbers of schoolchildren remain at risk from malaria-specific morbidity and mortality. Each year between 20-50% of schoolchildren, aged 10-14 years, living in malaria-endemic areas will experience a clinical attack of malaria (Clarke et al., 2004). Malaria accounts for 3-8% of all-cause absenteeism from school, and up to 50% of preventable absenteeism (Brooker et al., 2000). In addition, asymptomatic parasitaemia contributes to anaemia, reducing concentration and learning in the classroom (Holding \& Snow, 2001). Intermittent preventive treatment (IPT) delivered through schools is a simple intervention, which can be readily integrated into broader school health programmes. This study seeks to examine whether IPT can reduce malaria and anaemia amongst school-going children, and its consequent impact on school performance, in order to assess its suitability for inclusion as a standard intervention in school health programmes.
The efficacy of IPT is being evaluated in schoolchildren with a high-level of acquired immunity and ability to limit parasite growth, in whom most infections are asymptomatic and may go untreated.
The intervention: Intermittent preventive treatment of malaria administered each school term with the purpose to reduce asymptomatic parasitaemia and prevent clinical attacks, thereby reducing anaemia and school absenteeism, with consequences for improved attendance and concentration in class.
Schools are randomly allocated to one of two arms:
- Intervention schools: IPT given three times a year (once per term) + mass treatment with anthelminthics
- Control schools: mass treatment with anthelminthics only
Mass treatment with anthelminthics is carried out in all study schools twice annually in accordance with national policy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Intermittent preventive treatment (SP and amodiaquine)Intermittent preventive treatment with antimalarial drug combination(SP and amodiaquine) |
| 2 | Placebo comparator | Other: PlaceboDual placebo comparator |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Enrolled in primary school, and attending regularly
- Enrolled in nursery or classes 1-7
- Informed consent from parent or guardian
Key exclusion criteria (8 listed)
- Enrolled in primary class 8
- Haemoglobin level below 70g/L at baseline
- History of reaction to sulfa drugs (e.g. fansidar, septrin)
- History of severe skin reaction to any drug
- Withdrawal of parental consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent preventive treatment (SP and amodiaquine)Oral medication. SP: single dose given over one day; amodiaquine: 3 daily doses over 3 days. Dosage has given according to age. | Drug | 1 |
| PlaceboThree doses given over three days (Day 1: placebo SP + placebo AQ; Days 2 and 3: placebo AQ). Dosage given according to age | Other | 2 |
Primary outcome
Prevalence of anaemia (Hb <112g/L)
Time frame: March 2006
3 secondary outcomes
Prevalence of Plasmodium falciparum parasitaemia
Time frame: March 2006
Sustained attention
Time frame: March 2006
Mean haemoglobin
Time frame: March 2006
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
- BackgroundClarke SE, Brooker S, Jukes MCH, Njagi JK, Khasakhala L, Otido J, Crudder C, McGlone B, Magnussen P & Estambale BBA. (2006). Randomised controlled trial of intermittent preventive treatment in schoolchildren: Impact on malaria, anaemia & school performance [abstract]. American Journal of Tropical Medicine & Hygiene Suppl 75 (5): 123.
- BackgroundClarke S, Njagi J, Jukes M, Estambale B, Khasakhala L, Ajanga A, Luoba A, Otido J, Ochola S & Magnussen P. (2005). Intermittent preventive treatment in schools: Malaria parasitaemia, anaemia and school performance [abstract]. Acta Tropica, Suppl 95: S133.
- Derived from this study: PubMed 18620950Clarke SE, Jukes MC, Njagi JK, Khasakhala L, Cundill B, Otido J, Crudder C, Estambale BB, Brooker S. Effect of intermittent preventive treatment of malaria on health and education in schoolchildren: a cluster-randomised, double-blind, placebo-controlled trial. Lancet. 2008 Jul 12;372(9633):127-138. doi: 10.1016/S0140-6736(08)61034-X.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sian E Clarke, PhD principal investigator
London School of Hygiene and Tropical Medicine, University of London, UK
Simon J Brooker, PhD principal investigator
London School of Hygiene and Tropical Medicine, University of London, UK
Benson BA Estambale, MBChB, PhD principal investigator
University of Nairobi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intermittent preventive treatment (SP and amodiaquine) in people with Malaria, Falciparum, run by London School of Hygiene and Tropical Medicine at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of anaemia (Hb <112g/L) (time frame: March 2006). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00142246, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2017.